H.R. 6270 · 110th Congress
Access, Compassion, Care, and Ethics for Seriously Ill Patients Act
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Never voted on. It didn't reach a floor vote before the 110th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
WatsonSponsor7 cosponsors · 5 D, 2 R
7 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or…
What it does: CRS summary · Introduced in House · Jun 12, 2008
Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met.
Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act.
Establishes a procedure for accelerated approval of an investigational drug, biological product, or device that is reasonably likely to predict clinical benefit to a patient suffering from a serious or life-threatening condition.
Requires the Secretary to establish: (1) the Accelerated Approval Advisory Committee; (2) a new program to expand access to investigational treatments for individuals with serious or life threatening conditions and diseases; and (3) a demonstration project under the Medicare program to pay for drugs, biological, products, and devices approved under this Act.
Amends title XVIII (Medicare) of the Social Security Act to revise the definition of "medically accepted indication" to provide for coverage of a covered Part D drug based on the sponsor's or organization's determination that the drug is for a medically accepted indication.
Requires the Secretary to consider the clinical judgment and risks to the patient from the disease or condition in evaluating the safety and effectiveness of drugs, biological products, and devices that treat serious or life-threatening diseases or conditions, including the evaluation of nonstatistical information.
Requires any committee evaluating investigational drugs, devices, or biological product applications to have at least two patient representatives as voting members.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Access, Compassion, Care, and Ethics for Seriously Ill Patients Act
Also known as: ACCESS Act
Latest action (Jun 17, 2008): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Jun 12, 2008
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.